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LeukemiaNCT00899171

S9031-S9126-S9333-S9500-A, Studying Bone Marrow and Blood Samples From Patients With Acute Myeloid Leukemia

An observational study of Leukemia, run by SWOG Cancer Research Network.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Studying samples of bone marrow and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at bone marrow and blood samples from patients with acute myeloid leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
DNA analysis, DNA methylation analysis and RNA analysis
How many people
251 participants
Where
No sites listed yet
Study dates
Nov 2008to Sep 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients enrolled on S9031, S9333, S0106 or S0112 that consented to use of specimens for future research

DISEASE CHARACTERISTICS:

  • Pretreatment RNA specimens* available from patients with acute myeloid leukemia (AML) registered for front-line therapy on the following clinical trials:
  • SWOG-9031
  • SWOG-9126
  • SWOG-9333
  • SWOG-9500
  • Cryopreserved pretreatment cell specimens* available from a subset of patients (those who obtained a complete response [CR] and remained in CR without relapse for ≥ 2 years vs those with resistant disease [i.e., failed to achieve CR with evidence of persistent AML following induction therapy]) NOTE: All specimens currently available in the Southwest Oncology Group Myeloid Leukemia and MDS Repository at the University of New Mexico

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

About this study

Official title: S9031-S9126-S9333-S9500-A, Examination of the Prognostic Significance of AML-Specific and Age-Associated Genes in AML Patients

RATIONALE: Studying samples of bone marrow and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at bone marrow and blood samples from patients with acute myeloid leukemia.

Read the detailed description

OBJECTIVES:

  • To determine whether the expression of previously identified acute myeloid leukemia (AML)-specific and age-associated genes have prognostic significance in adult patients with AML.
  • To examine, preliminarily, if AML-specific and age-associated expression changes occur in the most primitive hematopoietic leukemia blasts (i.e., CD34+/38-).
  • To examine, preliminarily, whether methylation or histone modification of the IRF8 CPG island/promoter region is correlated with IRF8 gene expression in AML.

OUTLINE: This is a multicenter study.

Previously collected specimens of RNA from pre-treatment marrow or peripheral blood are obtained from a repository of SWOG clinical trials (SWOG-S9031, SWOG-9126, SWOG-9333, and SWOG-9500). Samples are analyzed for absolute expression levels of 23 selected genes and relative expression levels of splice variants via quantitative RT/PCR and GeneScan assays and linked to clinical and outcome data from the main SWOG database. Samples from a subset of patients are analyzed to confirm aberrant expression of acute myeloid leukemia-specific and age-associated genes in highly enriched population of leukemic blasts (CD34+/CD38- and CD34+/CD38+). DNA samples are also analyzed for correlation of IRF8 gene expression with methylation or histone modification of the IRF8 CPG island/promoter region.

Conditions
Leukemia
Being tested
DNA analysis, DNA methylation analysis, RNA analysis, gene expression analysis, reverse transcriptase-polymerase chain reaction
Keywords
adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, adult acute erythroid leukemia (M6), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), secondary acute myeloid leukemia
Medical subject headings
Leukemia, Congenital Abnormalities, Leukemia, Myeloid, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myelomonocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DNA analysisGenetic

  • DNA methylation analysisGenetic

  • RNA analysisGenetic

  • gene expression analysisGenetic

  • reverse transcriptase-polymerase chain reactionGenetic

  • laboratory biomarker analysisOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prognostic significance for complete response, overall survival, and relapse-free survival of total and relative expression levels (variant/wild type ratios) for each gene

    Measured: immediate

  2. Role of acute myeloid leukemia (AML)-specific and age-associated genes in the biology and prognosis of AML

    Measured: immediate

  3. Role of methylation and histone modification in IRF8 gene expression

    Measured: immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00899171
Sponsor's protocol ID
S9031-S9126-S9333-S9500-A
Other IDs
S9031-S9126-S9333-S9500-A, U10CA032102
Status last verified
Mar 2015
First submitted
9 May 2009
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • Ho PA, Kopecky KJ, Alonzo TA, Gerbing RB, Miller KL, Kuhn J, Zeng R, Ries RE, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Godwin JE, Reaman GH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Prognostic implications of the IDH1 synonymous SNP rs11554137 in pediatric and adult AML: a report from the Children's Oncology Group and SWOG. Blood. 2011 Oct 27;118(17):4561-6. doi: 10.1182/blood-2011-04-348888. Epub 2011 Aug 26.

    PubMed 21873548

  • Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.

    PubMed 25527568

  • Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.

    PubMed 24383844

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, run by SWOG Cancer Research Network.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prognostic significance for complete response, overall survival, and relapse-free survival of total and relative expression levels (variant/wild type ratios) for each gene (time frame: immediate). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00899171, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.

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